Devices
FDA has released a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligence and machine learning (AI/ML) in medical devices. The transcript notes the committee discussed the composition of the datasets on which the software “learns,” components of the
Drugs
FDA has given expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu. Xofluza was approved in 2018 in a tablet formulation for treating uncomplicated flu in patients
Biologics
FDA has accepted for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease
FDA Policy/General
Guide on Drugs for Cytomegalovirus in Transplants Federal Register notice: FDA makes available a final guidance on developing drugs for cytomegalovirus in transplantation. 11/20/2020 Guide on Posterior Cervical Screw Classification Federal Register notice: FDA makes available a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity
Drugs
Mallinckrodt has agreed to acquire U.S.-based Ocera Therapeutics, a clinical-stage biopharmaceutical company in a deal valued at about $117 million. The transaction gives Mallinckrodt Ocera’s developmental product OCR-002, an ammonia scavenger currently being studied to treat hepatic encephalopathy, a neuropsychiatric syndrome that is associated with
Drugs
Federal Register notice: FDA has made available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. The document is intended to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009.
FDA Policy/General
Federal Register notice: FDA is announcing the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in Combination Drug Regimens. The document describes the agency’s current recommendations on including relevant information in labeling for oncology drugs approved for use in combination drug regimens, including important consideration
Drugs
Johnson & Johnson (J&J) subsidiary Medical Device Business Services has agreed to pay $10 million to settle allegations under the False Claims Act that former J&J subsidiary Therakos promoted Uvar XTS and Cellex extracorporeal photopheresis systems for unapproved uses in pediatric patients between 2006 and 2012.
FDA Policy/General
Federal Register notice: FDA has updated its ongoing listing of issued and reissued Emergency Use Authorizations (EUAs) for medical devices related to the Covid–19 public health emergency. The authorizations contain, among other things, conditions on the emergency use of the EUA products. To view the notice, click here.
Drugs
FDA has issued a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs). It discusses when drug developers should conduct
Biologics
Pfizer and BioNTech have submitted an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 data showing a vaccine efficacy rate of 95%. The latest analysis is based on 170 Covid cases, of which 162 were observed in the placebo group versus eight in
Drugs
Fresenius Kabi has recalled a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vial due to a trace amount of lidocaine present in the lot. To date, no adverse drug experience reports have been received for the
Drugs
FDA has published a draft guidance, Cross Labeling Oncology Drugs in Combination Regimens, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important consideration for cross labeling of the drugs. The document says it does
Drugs
The Stericycle Recall Insights report for the third quarter of 2020 shows that drug recalls increased markedly in the quarter while medical device recalls fell to their lowest level in several quarters. The report says that drug recall activity increased by 49.5% in the third quarter, with affected units
Drugs
FDA has published a draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, with answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The document says the question-and-
Drugs
FDA has accepted for review an Alvotech USA BLA for its AVT02, a proposed biosimilar to the reference product AbbVie’s Humira (adalimumab) with high concentration dosage forms. A company statement says AVT02 is one of five product candidates from Alvotech that will be commercialized in the U.S. by
FDA Policy/General
Federal Register notice: FDA makes available 30 additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Richard M. Simon from providing services in any capacity to a person that has an approved or pending drug product application. In January, Simon was convicted on one count of racketeering conspiracy related to his role as regional sales manager
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) has updated its core launch review process as explained in new frequently asked questions. OPDP says it has been evaluating trends in core launch material submissions such as sales and visual aids, patient brochures, and professional journal and magazine ads from sponsors
Biologics
FDA has posted a page to give vaccine product manufacturers information about electronically submitting postmarket individual case safety reports to the Vaccine Adverse Events Reporting System (VAERS). The notice says CBER has implemented the International Council on Harmonization’s Individual Case Study Report specification to support electronic reporting of vaccine
Devices
FDA has approved Armis Biopharma’s VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. The company says the device is designed to make such surgical corrections more accessible to patients through shorter time
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by the Regenerative Cell Institute, Las Vegas, NV, indicates the firm markets cellular products derived from either human adipose tissue or umbilical cord to consumers to treat various diseases or conditions. An 11/10